Data Standards Monthly Project Lead 30 July 2018 Meeting Minutes

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  • Project team updates


  • Dmitry Kolosov
  • Jane Lozano
  • Lex Jansen
  • Lisa Brooks
  • Mike Hamidi
  • Nate Friemark
  • Wendy Dobson

Meeting Discussion

Working Group Lead Minutes
Best Practices for Data Collection Instructions Todd Bazin Team has finished disposition and is now working on adverse events. Todd is going to collaborate with the Standard Analysis and Code Sharing working group on adverse events. Meetings are scheduled in September and October.
Best Practices for Metadata Documentation (Define-XML document versus reviewer's guide) Sandy VanPelt Nguyen Team continuing on white paper. Suggestions for updating the cSDRG template were provided to Jane and were discussed in a LDCP&R meeting. Feedback was provided to Sandy. Jane to follow up with her.
CDISC Primer Scott Bahlavooni and Jasmine Kestermont The CDISC standards page has been restructured to be more interactive and include visualizations. CDISC and PhUSE to determine how to best collaborate on this project. Presented at the July webinar. Out of scope are any FAQs as they are addressed by the SDTM ADaM Implementation FAQ project team.
Clinical Legacy Data Conversion Plan & Report Lisa Brooks and Jane Lozano cSDRG deliverables have been sent to Wendy for discussion at the 10 August CSS Steering Committee meeting. Deliverables include the cSDRG template, completion guidelines, two new example documents, updated existing example documents, and a summary of the changes made to the template. The ADRG template has been updated and the team is working on updating one of the example documents.
Data Reviewer's Guide in XML Mike Hamidi The project deliverables are ready for the CSS Steering Committee and will be included in the agenda for the 10 August meeting. There are many deliverables. The main ones are 1) csdrg.xml 2) sdrg1-0-0.xsl 3) schema folder 4) sdrg-ns.html. This is a prototype only and not the final product. Mike is available on 10 August and will check with a couple other people within his team as he would like them present to answer any questions.
Data Standards for Observational Studies Yuliia Bahatska and Vladlen Ivanushkin Kick-off meeting planned. Did not have time to present at the July webinar. There are enough people to get started.
Define-XML v2.0 Completion Guidelines Marcellina Hungary and Prafulla Girase Timeline updated to provide deliverable to Jane and Lisa in August. Team members include representatives from CDISC Development Team. However, a broader CDISC review will occur after the Steering Committee has reviewed the document. (No new update from last month)/Last week of July for deliverables.
Define-XML v2.0 Stylesheet Recomendation) Dmitry Kolosov and Lex Jansen The deliverables are ready for review by the CSS Steering Committee. The zip file that Dmitry sent to Wendy, Lisa, and Jane can be provided to the steering committee. Also, Dmitry and Wendy have had discussions about the survey which will be included in the deliverables sent to the steering committee.
Industry Experiences Submitting Standardised Study Data to Regulatory Authorities Todd Case and Vincent Guo The project team has divided into three sub-teams. Not sure if one white paper or one from each sub-team.
SDTM ADaM Implementation FAQ Bhavin Bhusa, Peter Van Reusel, and Kiran Kundarapu Ongoing project. Amy from CDISC is replacing Peter due to his new position at CDISC. Team is going to write two white papers which will be shared with the CSS Steering Committee at the meeting on 10 August. Documents created to request FDA support. Two new questions and answers have been published.

Wendy will have a discussion with Chris regarding the storage location for deliverables that are not published yet but teams are working on them. Should the Wiki be the place for these documents? |- The next meeting is 27 August which is a bank holiday in the UK. Jane will send Wendy her joinme information so that the teams can still meet

Action Items

  • [Jane] Follow-up with Sandy regarding the white paper.
  • [Wendy] Follow-up with Chris regarding where deliverables should reside until they are ready for public review.